Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy

This study is ongoing, but not recruiting participants.

First Received: September 1, 2006 Last Updated: May 26, 2009 History of Changes

Sponsor:	Tuen Mun Hospital
Collaborator:	Eli Lilly and Company
Information provided by:	Tuen Mun Hospital
ClinicalTrials.gov Identifier:	NCT00371956

Purpose

This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the prevention of bone mineral density loss in patients receiving long term corticosteroids.

Condition	Intervention	Phase
Osteoporosis	Drug: raloxifene Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-Blind Placebo-Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: Raloxifene hydrochloride Raloxifene Corticosteroids

U.S. FDA Resources

Further study details as provided by Tuen Mun Hospital:

Primary Outcome Measures:

Bone turnover and bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Fracture, safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	September 2006
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator raloxifene	Drug: raloxifene 60mg/day
2: Placebo Comparator placebo arm	Drug: placebo tab 1 daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone <= 10 mg/day or equivalent).
Baseline bone mineral density (BMD) of the lumbar spine T score < -1.0.

Exclusion Criteria:

Patients with a history of thromboembolism.
Patients with positive antiphospholipid antibodies.
History of allergic reactions or intolerance to raloxifene or other SERMs.
Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
Patients with abnormal uterine bleeding of unknown etiology.
Patients with serum creatinine level of >= 200 umol/L.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371956

Locations

China
Tuen Mun Hospital
Hong Kong, China

Sponsors and Collaborators

Tuen Mun Hospital

Eli Lilly and Company

Investigators

Principal Investigator:

CC MOK, MD, FRCP

Tuen Mun Hospital, Hong Kong

More Information

No publications provided

Responsible Party:	Tuen Mun Hospital, Hong Kong ( CC Mok )
Study ID Numbers:	HARECCTR0500058
Study First Received:	September 1, 2006
Last Updated:	May 26, 2009
ClinicalTrials.gov Identifier:	NCT00371956 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Tuen Mun Hospital:

raloxifene
estrogen
receptor
modulation

osteoporosis
steroid
Steroids

Additional relevant MeSH terms:

Estrogen Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Bone Diseases
Pharmacologic Actions
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases
Osteoporosis, Postmenopausal

ClinicalTrials.gov processed this record on February 08, 2010